Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline Study OECD 402 with GLP compliance

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Identity: Delta-Valerolactone

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: male animals approx. 8 weeks, female animals approx. 12 weeks
- Weight at study initiation: 200-250 g
- Fasting period before study: No
- Housing: single
- Diet: VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany
- Water: Tap water, ad libitum
- Acclimation period: Acclimatization period of at least 5 days before the beginning of the experimental phase; during the acclimatization period, the animals were accustomed to the environmental conditions of the study and to the diet.

ENVIRONMENTAL CONDITIONS
- Temperature: 22°C ± 3°C
- Humiddity: 30 – 70%
- Photoperiod (hrs dark / hrs light): 12 h / 12 h (6.00 a.m. – 6.00 p.m. / 6.00 p.m. – 6.00 a.m.)

IN-LIFE DATES: From: 2012-01-23 To: 2012-02-15

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal and dorso-lateral parts of the trunk
- % coverage: 10 % of the total body surface area
- Type of wrap if used: air-permeable dressing (4 layers of absorbent gauze and stretch bandage)

REMOVAL OF TEST SUBSTANCE
- Washing: rinsing of the application site with warm water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied: 4.5 mL/kg bw
- Concentration: undiluted
- Constant volume or concentration used: constant concentration

VEHICLE
- unchanged (no vehicle)
Duration of exposure:
24 h
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Recording of clinical signs several times on the day of administration, and at least once daily thereafter
each workday for the individual animals. Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of
observation
- Necropsy of survivors performed: yes, incl. gross-pathology examination
- Other examinations performed: scoring of skin findings 30 – 60 minutes after removal of the semi-occlusive dressing (day 1), weekly thereafter and
on the last day of observation, mortality or moribund animals at least once each workday.
Statistics:
Not performed.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed.
Clinical signs:
No signs of systemic toxicity or skin effects were observed in the animals. No local findings were observed.
Body weight:
The mean body weight of the animals increased within the normal range throughout the study period with the exception of one female which showed
stagnation of body weight after the first post-exposure week, but gained weight in a normal range during the second week.
Gross pathology:
No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study.

Applicant's summary and conclusion